04-3711. National Toxicology Program (NTP) Center for the Evaluation of Risks to Human Reproduction (CERHR) Announcement of Availability of the Draft Expert Panel Report on Acrylamide; Announcement of Expert Panel Meeting on Acrylamide; Request for ...

SUMMARY:

The NTP CERHR announces:

(1) availability of sections 1-4 of the draft expert panel report on acrylamide on March 15, 2004, and solicits written public comments on the report by April 29, 2004.

(2) the acrylamide expert panel meeting May 17-19, 2004, at the Holiday Inn Old Town Select, Alexandria, Virginia and invites the public to present oral comments at this meeting.

Questions ublic comments should be directed to Dr. Michael Shelby, CERHR Director (contact information below).

Draft Expert Panel Report on Acrylamide Available

The CERHR announces the availability of the draft expert panel report on acrylamide (CAS RN 79-06-1). Acrylamide is used in the production of polyacrylamide, which is used in water treatment, pulp and paper production, mineral processing, and scientific research. Polyacrylamide is used in the synthesis of dyes, adhesives, contact lenses, soil conditioners, cosmetics and skin creams, food packaging materials, and permanent press fabrics. In scientific research, it is used in molecular biology procedures such as electrophoresis. Acrylamide is a neurotoxicant and in animal studies has been shown to be a carcinogen, germ cell mutagen, and reproductive toxicant. The CERHR selected acrylamide for expert panel evaluation because of recent public concern for human exposures through its presence in some starchy foods cooked at high temperatures. In addition, recent data are available on human exposure, bioavailability, and reproductive toxicity.

Each draft expert panel report has the following sections:

1.0 Chemistry, Use, and Human Exposure

2.0 General Toxicological and Biological Effects

3.0 Developmental Toxicity Data

4.0 Reproductive Toxicity Data

5.0 Summary, Conclusions, and Critical Data Needs (to be prepared at expert panel meeting)

Sections 1-4 will be available to the public on March 15, 2004, and can be obtained electronically on the CERHR Web site (http://cerhr.niehs.nih.gov) or in hard copy or compact disk by contacting Dr. Michael Shelby, Director CERHR [NIEHS, 79 T.W. Alexander Drive, Building 4401, Room 103, P.O. Box 12233, MD EC-32, Research Triangle Park, NC 27709, telephone: [phone]; facsimile: [phone]; [e-mail]].

Request for Written Comments on Draft Expert Panel Report

The CERHR invites written public comments on sections 1-4 of the draft expert panel report on acrylamide. Comments can be submitted in hard copy or electronic format and must be received by the CERHR by April 29, 2004. These comments will be distributed to the expert panel and CERHR staff for consideration in revising the draft report and in preparing for the expert panel meeting. They will be posted on the CERHR web site prior to the expert panel meeting. These comments should be sent to Dr. Michael Shelby at the address provided above. Persons submitting written comments are asked to include their name and contact information (affiliation, mailing address, telephone and facsimile numbers, e-mail, and sponsoring organization, if any).

Expert Panel Meeting Planned

The CERHR will hold an expert panel meeting May 17-19, 2004, at the Holiday Inn Old Town Select 480 King Street Alexandria, VA 22314 (telephone: [phone], facsimile: 703-684-6508). The CERHR has asked the expert panel to review the scientific evidence regarding the potential reproductive and/or developmental toxicity associated with exposure to acrylamide. The expert panel will review and revise the draft expert panel report and reach conclusions regarding whether exposure to acrylamide is a hazard to human development or reproduction. The expert panel will also identify data gaps and research needs.

This meeting is open to the public and attendance is limited only by the available meeting room space. The meeting will begin at 8:30 a.m. each day. On May 17 and 18, it is anticipated that a lunch break will occur from noon-1 p.m. and that the meeting will adjourn 5-6 p.m. The meeting is expected to adjourn by noon on May 19; however, adjournment may occur earlier or later depending upon the time needed by the expert panel to complete its work. Anticipated agenda topics for each day are listed below. Following the expert panel meeting and completion of the expert panel report, the CERHR will post the report on its web site and solicit public comment through a Federal Register notice.

Preliminary Meeting Agenda

Meeting begins at 8:30 a.m. each day.

Lunch break anticipated from noon-1 p.m.

May 17, 2004

Opening remarks

Oral public comments (7 minutes per speaker; one representative per group, see below)

Review of sections 1-4 of the draft expert panel report on acrylamide

Discussion of Section 5.0 Summary, Conclusions, and Critical Data Needs

May 18, 2004

Discussion of Section 5.0 Summary, Conclusions, and Critical Data Needs

Preparation of draft summaries and conclusion statements

May 19, 2004

Presentation, discussion of, and agreement on summaries and conclusions

Closing comments

Oral Public Comments Welcome at Expert Panel Meeting

Time is set aside on May 17, 2004, for the presentation of oral public comments at the expert panel meeting. To facilitate planning, those persons wishing to make oral public comments are asked to contact Dr. Shelby by May 10 (contact information provided above). Seven minutes will be available for each speaker (one speaker per organization). When registering to comment orally, please provide your name, affiliation, mailing address, telephone and facsimile numbers, email and sponsoring organization (if any). If possible, also send a copy of the statement or talking points to Dr. Shelby by May 10. This information will be provided to the expert panel to assist them in identifying issues for discussion and will be noted in the meeting record. Registration for presentation of oral comments will also be available at the meeting on May 17, 2004 (7:30-8:30 a.m.). Those persons registering at the meeting are asked to bring 20 copies of their statement or talking points for distribution to the expert panel and for the record.

Acrylamide Expert Panel

The CERHR expert panel is composed of independent scientists selected for their scientific expertise in reproductive and/or developmental toxicology and other areas of science relevant for this review.

Expert Panel Members and Affiliation

Jeanne M. Manson Ph.D., M.S.C.E., Chairperson, The Children's Hospital of Philadelphia, Philadelphia, PA

Michael Brabec, Ph.D., Eastern Michigan University, Ypsilanti, MI

Judy Buelke-Sam, M.A. , Toxicology Services, Greenfield, IN

Gary P. Carlson, Ph.D., Purdue University, West Lafayette, IN

Robert E. Chapin, Ph.D., Pfizer Inc., Groton, CT

John B. Favor, Ph.D., GSF—National Research Center for Environment and Health, Neuherberg, Germany

Lawrence J. Fischer, Ph.D., Michigan State University, East Lansing, MI

Dale Hattis, Ph.D., Clark University, Worcester, MA

Peter J. Lees, Ph.D., The Johns Hopkins University, Baltimore, MD

Sally Perreault-Darney, Ph.D., US Environmental Protection Agency, Research Triangle Park, NC

Joe C. Rutledge, MD, Children's Hospital and Regional Medical Center, Seattle, WA

Thomas J. Smith, Ph.D., C.I.H., Harvard School of Public Health, Boston, MA

Raymond R. Tice, Ph.D., Integrated Laboratory Systems, Inc., Research Triangle Park, NC

Peter K. Working, Ph.D., Cell Genesys, Inc., South San Francisco, CA

Background Information About the CERHR

The NTP established the NTP CERHR in June 1998 [Federal Register, December 14, 1998 (Volume 63, Number 239, page 68782)]. The CERHR is a publicly accessible resource for information about adverse reproductive and/or developmental health effects associated with exposure to environmental and/or occupational exposures. Expert panels conduct scientific evaluations of agents selected by the CERHR in public forums.

The CERHR invites the nomination of agents for review or scientists for its expert registry. Information about CERHR and the nomination process can be obtained from its homepage (http://cerhr.niehs.nih.gov) or by contacting Dr. Shelby (contact information provided above). The CERHR selects chemicals for evaluation based upon several factors including production volume, extent of human exposure, public concern, and published evidence of reproductive or developmental toxicity.

CERHR follows a formal, multi-step process for review and evaluation of selected chemicals. The formal evaluation process was published in the Federal Register notice July 16, 2001 (Volume 66, Number 136, pages 37047-37048) and is available on the CERHR website under “About CERHR” or in printed copy from the CERHR.

Dated: February 11, 2004.

Samuel H. Wilson,

Deputy Director, National Institute of Environmental Health Sciences.